TEMPO 451457V0Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705032008174), received between Aug 4, 2025 and Sep 15, 2025 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Crack” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjurySep 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, A 4F 65CM RIM TEMPO DIAGNOSTIC CATHETER TORE WHEN WITHDRAWN OVER THE BIFURCATION AND HAD TO BE RETRIEVED WITH A SNARE. THERE WAS NO REPORTED PATIENT INJURY. DURING USE, THE DEVICE CRACKED ; THERE WAS NO DEVICE SEPARATION, AND THE CATHETER DID NOT BECOME ENTRAPPED. SNARE RETRIEVAL WAS IDENTIFIED AS THE ANTICIPATED METHOD; HOWEVER, NO SEPARATION OCCURRED. THE PRODUCT WAS STORED/HANDLED AND PREPPED PER THE IFU, WITH NO DAMAGE NOTED PRIOR TO OPENING AND NO DIFFICULTY REMOVING FROM PACKAGING OR DURING PREPARATION. THE DEVICE WAS REMOVED FROM STERILE PACKAGING BY THE HUB AND WAS NOT TORQUED/STEERED BY THE HUB. TARGET VESSEL CHARACTERISTICS INCLUDED MILD CALCIFICATION. THE ACCESS SITE VESSEL CHARACTERISTICS WERE NOT REPORTED. PROCEDURAL IMAGING (CD) IS NOT AVAILABLE. THE DEVICE WAS RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23051580 ↗
• MalfunctionAug 4, 2025Crack; Degraded; Crack; Degraded

  AS REPORTED, TWO 4F RIM 65CM TEMPO DIAGNOSTIC CATHETERS WERE FOUND TO BE STARTING TO CRACK, IDENTIFIED ACROSS TWO SEPARATE LOT NUMBERS. THERE WAS NO REPORTED PATIENT INJURY. THERE WERE DAMAGES FOUND ON THE DEVICE OR DEVICE PACKAGING PRIOR TO OPENING. THE CRACKS ON THE DEVICES WERE FOUND BEFORE USE, WHILE ON THE SHELF. THE DEVICE WAS STORED AND PREPPED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS NOT TORQUED OR "STEERED" BY THE HUB AS IT WAS NEVER OPENED. THE USER WAS TRAINED IN THE USE OF THE DEVICE. THOUGH ONLY 2 DEVICES WERE FOUND TO HAVE CRACKS, 7 DEVICES TOTAL ARE BEING RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22709393 ↗
• MalfunctionAug 4, 2025Crack; Degraded; Crack; Degraded

  AS REPORTED, TWO 4F RIM 65CM TEMPO DIAGNOSTIC CATHETERS WERE FOUND TO BE STARTING TO CRACK, IDENTIFIED ACROSS TWO SEPARATE LOT NUMBERS. THERE WAS NO REPORTED PATIENT INJURY. THERE WERE DAMAGES FOUND ON THE DEVICE OR DEVICE PACKAGING PRIOR TO OPENING. THE CRACKS ON THE DEVICES WERE FOUND BEFORE USE, WHILE ON THE SHELF. THE DEVICE WAS STORED AND PREPPED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS NOT TORQUED OR "STEERED" BY THE HUB AS IT WAS NEVER OPENED. THE USER WAS TRAINED IN THE USE OF THE DEVICE. THOUGH ONLY 2 DEVICES WERE FOUND TO HAVE CRACKS, 7 DEVICES TOTAL ARE BEING RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22708557 ↗